Bioethics can be measured to encourage best practices

Bioethicist Dr. Jennifer Miller was the featured speaker at Pope John Paul II High School’s Speaker Series on Thursday, Oct. 22, the feast day of the school’s patron, St. John Paul II. The Speaker Series is held each year to highlight a subject that was important in the life and pontificate of St. John Paul II. This year, the theme is the Catholic Church’s relationship with science, which was a topic St. John Paul II addressed frequently. Dr. Miller, the founding president of the nonprofit Bioethics International, spoke about the ethics of developing new drugs and medications and making them accessible. Photo by Andy Telli

Ethical actions in a corporate setting can be measured and the results used to improve an industry’s standards, said Dr. Jennifer Miller, a bioethicist who was the featured speaker at Pope John Paul II High School’s Speaker Series held during Pope Week, when the school honors its namesake, St. John Paul II.

“Bioethics isn’t just a philosophical discussion of what you should or shouldn’t do,” said Miller, an assistant professor of medical ethics in the Department of Population Health of NYU Langone Medical School and the founding president of the nonprofit agency Bioethics International. “It can be empirical, just like what a scientist does in a lab.”

Miller has used such an empirical approach to create a scorecard to measure and rank whether pharmaceutical companies are meeting ethical standards in researching new drugs and then making them accessible to patients who need them.

The pharmaceutical companies have lost the trust of much of the American public, Miller said. Only 12 percent of Americans think the companies are generally ethical and 70 percent think they put profits before people, she said.

The industry used to be among the most respected by the American public, but today it ranks near the bottom of the list just above Wall Street and the tobacco companies, she said.

To address similar problems in the past, other industries have used accrediting agencies and rankings to promote best practices, Miller said.

She has developed an index for pharmaceutical companies to do the same. She’s hopeful the index will signal to companies where good practices are being used and incentivize reforms where they aren’t. “It can be a good catalyst for information exchange,” Miller said. “This program has a lot of hope.”

Pharamceutical companies have been receptive to her work, Miller said. “Companies know they have a trust problem,” Miller said. “They are interested in the index as a tool to rebuild the public’s trust.”

The index addresses several ethical areas of concern in developing new drugs and medicines and making them accessible. The first has to do with the design of the clinical trials conducted on new drugs to determine if they are effective and safe. The concern is that the trials can be designed in a biased way to make the drugs look better than they actually are, Miller said.

Monitoring for this type of bias lies outside any of the traditional gatekeepers, such as government regulatory agencies, Miller said.

Another area of concern is that 40-60 percent of the clinical trials are conducted outside of the United States. One reason to do that is determine if the drug is effective for different populations around the world, Miller said.

But differences in the health characteristics of a population in a developing country might affect the effectiveness of the drug in the United States, Miller said.

There also is a question of the quality of the consent for the patients participating in such clinical trials, Miller said. For some patients, agreeing to participate in a trial might be the only way they can gain access to health care, she explained.

Another question is whether the drug companies help the patients in the trials get access to the drugs after they’ve been approved, Miller said.

Another concern is what happens to the results of the trials. In some cases, the results of a clinical trial might never be released, Miller said, and there is a fear that a company will release the results of only those trials that put the drugs being tested in the best light.

Not releasing the results can also slow innovation, Miller said, because other scientists don’t have the opportunity to learn from previous failures.

There are concerns about how companies market their drugs and whether the cost of a drug makes it hard for the people who need it to get access to it, Miller said.

But even if a drug is free, that doesn’t guarantee access, Miller said. People who live in remote areas of a developing country with a limited health care system might be unable to get access to a drug no matter its cost, Miller said. And some countries don’t have an adeqate electrical grid to make sure drugs can be refrigerated so they can be stored and transported safely at the proper temperatures.

There are some things pharmaceutical companies might be able to do that could ease access problems, Miller said, such as developing more drugs that remain stable when stored or transported at higher temperatures.

“With every concern we have my hope is we can come up with ways to measure it,” Miller said. “The scorecard is not meant to be destructive but be a positive catalyst for change.”

Miller hopes to release a scorecard for each drug approved for use each year to measure how the company met these concerns.

JPII High School established its speaker series to address topics that were important in the life and pontificate of St. John Paul II. This year’s theme is the Catholic Church’s relationship with science, which St. John Paul addressed often during his life, said Dr. Brad Peper, director of the JPII Center for Scholarly Engagement and chair of the school’s Theology Department.

“In his ‘Message to the Pontifical Academy of Sciences: On Evolution’ St. John Paul II encouraged fruitful dialogue to occur between the sciences and the Catholic Church in order to expand and enlighten each other’s respective works,” Peper said. “Following his predecessors, he continuously sought to tear down the false barrier placed between theology and science, which had become so prevalent in the modern era, in order to restore the notion that ‘truth cannot contradict truth.’ Ultimately, JPII emphasized the common end that both science and religion share: to ‘be at the service of man.’”